Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Prostatic Hyperplasia Clinical Trial

— SAMBA-Thailand  

Official title:

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401661
• Other study ID #: ALFUS_L_01241
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2006
• Last updated: September 14, 2009
• Start date: June 2006

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary objective:

• End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.

Secondary objectives:

• MSHQ-EjD improvement by visit

• Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit

• Onset of action of XATRAL 10mg OD

• Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion criteria:

• Patients suffering from moderate to severe LUTS suggestive of BPH

• I-PSS total score = 8

• Patients sexually active

Exclusion criteria:

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition

• Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period

• Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer

• Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion

• Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion

• History of postural hypotension or syncope

• Known hypersensitivity to alfuzosin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Alfuzosin
One tablet of 10mg once daily at the end of evening meal

Locations

Country	Name	City	State
Thailand	Sanofi-Aventis	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSHQ Ejaculation score		End of treatment	No
Secondary	MSHQ Ejaculation score		After 4 weeks of treatment	No
Secondary	MSHQ Ejaculation score		After 12 weeks of treatment	No
Secondary	Acute Urinary Retention		End of treatment	No
Secondary	Correlation between MSHQ and IPSS		End of treatment	No
Secondary	I-PSS total score		After 1 week of treatment	No
Secondary	I-PSS total score		After 4 weeks of treatment	No
Secondary	I-PSS total score		After 12 weeks of treatment	No
Secondary	I-PSS total score		End of treatment	No
Secondary	IPSS total score decrease = 3 points		End of treatment	No
Secondary	IPSS: filling sub-score		After 1 week of treatment	No
Secondary	IPSS: filling sub-score		After 4 weeks of treatment	No
Secondary	IPSS: filling sub-score		After 12 weeks of treatment	No
Secondary	IPSS: filling sub-score		End of treatment	No
Secondary	IPSS: nocturia symptoms sub-score		After 1 week of treatment	No
Secondary	IPSS: nocturia symptoms sub-score		After 4 weeks of treatment	No
Secondary	IPSS: nocturia symptoms sub-score		After 12 weeks of treatment	No
Secondary	IPSS: nocturia symptoms sub-score		End of treatment	No
Secondary	IPSS: voiding sub-score		After 1 week of treatment	No
Secondary	IPSS: voiding sub-score		After 4 weeks of treatment	No
Secondary	IPSS: voiding sub-score		After 12 weeks of treatment	No
Secondary	IPSS: voiding sub-score		End of treatment	No
Secondary	MSHQ ejaculation: erection sub-score		After 4 weeks of treatment	No
Secondary	MSHQ ejaculation: erection sub-score		After 12 weeks of treatment	No
Secondary	MSHQ ejaculation: erection sub-score		End of treatment	No
Secondary	MSHQ ejaculation: satisfaction sub-score		After 4 weeks of treatment	No
Secondary	MSHQ ejaculation: satisfaction sub-score		After 12 weeks of treatment	No
Secondary	MSHQ ejaculation: satisfaction sub-score		End of treatment	No
Secondary	Quality of Life		After 4 weeks of treatment	No
Secondary	Quality of Life		After 12 weeks of treatment	No
Secondary	Quality of Life		End of treatment	No